Neurotrophins Implications in Primary Sjögren Syndrome (Neuro-SGSp)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01081184
First received: March 3, 2010
Last updated: April 16, 2013
Last verified: March 2010
  Purpose

Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.


Condition Intervention
Primary Sjögren Syndrome
Biological: blood sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurotrophins Implications in Primary Sjögren Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.


Secondary Outcome Measures:
  • Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjonctival production by flow cytometry.


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
primary Sjögren syndrome Biological: blood sample
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
Other Names:
  • Salivary sicca syndrome will be evaluated.
  • Saliva fluid will be collected.
  • Ocular sicca syndrome will be evaluated.
  • A conjonctival cytological impression will be done.
Healthy volunteers Biological: blood sample
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
Other Names:
  • Salivary sicca syndrome will be evaluated.
  • Saliva fluid will be collected.
  • Ocular sicca syndrome will be evaluated.
  • A conjonctival cytological impression will be done.

Detailed Description:

2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.

Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjunctival production by flow cytometry.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People with primary Sjögren syndrome

People free of disease : healthy volunteers

Criteria

Inclusion Criteria:

Arm : primary Sjögren syndrome:

  • All patients must fulfill the revised criteria for primary Sjögren syndrome.
  • Age of entry into the study ≥ 18 yrs.
  • Affiliated or profit patient of a social security system.
  • Informed consent signed up.

Arm : healthy volunteers:

  • All patient free of autoimmune disease.
  • Age of entry into the study ≥ 18 yrs.
  • Affiliated or profit patient of a social security system.
  • Informed consent signed up.

Exclusion Criteria:

  • Patient with psychiatric disorders not related with antiphospholipid syndrome and / or cerebral complication of SGSp.
  • Addictive behaviors (alcoholism, cocaine or opioid abuse).
  • Patient with anti-depressive drugs.
  • Patient with concurrent malignancy
  • Pregnancy
  • Patients under measure of maintenance of justice.
  • Patients unable to understand or to participate to the study.
  • Child and major patients making the object of a measure of lawful protection.
  • Patients deprived of freedom.

Exclusion criteria for control group

  • Autoimmune disease.
  • Steroid treatment (>20 mg/day).
  • Immunosuppressive treatment.
  • Concurrent malignancy.
  • Concurrent psychiatric disorders.
  • Anti-depressive drugs.
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081184

Locations
France
Médecine Interne
Limoges, France, 87142
Opthalmologie
Limoges, France, 87142
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Anne-Laure FAUCHAIS, MD Limoges UH
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01081184     History of Changes
Other Study ID Numbers: I08010
Study First Received: March 3, 2010
Last Updated: April 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
primary Sjögren syndrome
neurotrophins
B cell
sicca syndrome
T cell

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014